Central Venous CatheterNCT03025178
Optimal Insertion Depth of Left Internal Jugular Vein Catheter in Infants
A study testing 4Fr central venous catheter insertion in people with Central Venous Catheter and Infant, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We previously performed a study to create formula for the optimal insertion depth of left internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found that two calculation methods using height and the distance between landmarks (0.11 × height (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55… Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Central Venous Catheter, Infant
- What is being tested?
- 4Fr central venous catheter insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Mar 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- An infant requiring a central venous catheter during surgery
Who cannot join
- Extracardiac vascular anomaly
- Dextrocardia
- Anatomical abnormality in neck and thorax
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation of Predictive Formula for Optimal Insertion Depth of Left Internal Jugular Venous Catheter in Infants
We previously performed a study to create formula for the optimal insertion depth of left internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found that two calculation methods using height and the distance between landmarks (0.11 × height (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the most prominent point of the sternal head of the left clavicle, and B was the midpoint of the perpendicular line drawn between the sternal head of the right clavicle and an imaginary line between the nipples) were clinically feasible to determine the insertion depth of left internal jugular vein catheter. In this study, we will compare the actual insertion depth with the insertion depth determined from above two calculation methods in other 46 infants.
Read the detailed description
determine the optimal insertion depth of left internal jugular vein catheter in infants
- Conditions
- Central Venous Catheter, Infant
- Being tested
- 4Fr central venous catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4Fr central venous catheter insertionProcedure or surgery
The central venous catheter is placed at left internal jugular vein in infant, and its tip is confirmed by transthoracic echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Central venous catheterization | Experimental | Central venous catheterization will be performed using 4Fr central venous catheter at left internal jugular vein in infant. The tip of central venous catheter will be confirmed by transthoracic echocardiography. The actual insertion depth of central venous catheter will be compared to the predicted insertion depth derived from two calculation methods using height and the distance between the anatomical landmarks. Receives: Procedure: 4Fr central venous catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The actual insertion depth of central venous catheter
The actual insertion depth of central venous catheter placed at left internal jugular vein
Measured: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
Secondary outcomes (1)
The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
Measured: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start8 Mar 2017
- Primary completion9 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025178
- Sponsor's protocol ID
- H1701-038-821
- Status last verified
- Sep 2019
- First submitted
- 17 Jan 2017
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of Predictive Formula for Optimal Insertion Depth of Left Internal Jugular Venous Catheter in Infants
- ClinicalTrials.gov ID
- NCT03025178
- Acronym / sponsor ID
- H1701-038-821
- Conditions
- Central Venous Catheter, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We previously performed a study to create formula for the optimal insertion depth of left internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found that two calculation methods using height and the distance between landmarks (0.11 × height (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the most prominent point of the sternal head of the left clavicle, and B was the midpoint of the perpendicular line drawn between the sternal head of the right clavicle and an imaginary line between the nipples) were clinically feasible to determine the insertion depth of left internal jugular vein catheter. In this study, we will compare the actual insertion depth with the insertion depth determined from above two calculation methods in other 46 infants.
Detailed description
determine the optimal insertion depth of left internal jugular vein catheter in infants
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Central venous catheterization | Experimental | Procedure: 4Fr central venous catheter insertionCentral venous catheterization will be performed using 4Fr central venous catheter at left internal jugular vein in infant. The tip of central venous catheter will be confirmed by transthoracic echocardiography. The actual insertion depth of central venous catheter will be compared to the predicted insertion depth derived from two calculation methods using height and the distance between the anatomical landmarks. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- An infant requiring a central venous catheter during surgery
Key exclusion criteria (3 listed)
- Extracardiac vascular anomaly
- Dextrocardia
- Anatomical abnormality in neck and thorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4Fr central venous catheter insertionThe central venous catheter is placed at left internal jugular vein in infant, and its tip is confirmed by transthoracic echocardiography. | Procedure or surgery | Central venous catheterization |
Primary outcome
The actual insertion depth of central venous catheter
Time frame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
The actual insertion depth of central venous catheter placed at left internal jugular vein
1 secondary outcome
The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
Time frame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soo Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4Fr central venous catheter insertion in people with Central Venous Catheter and Infant, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The actual insertion depth of central venous catheter (time frame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.